Safety Reports. In accordance with FDA requirements, the Sponsor will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in the Protocol(s). The Sponsor must provide the other Party with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human Subjects in research conducted under this CRADA.
Safety Reports. Institution and Investigator must record and report all serious AEs in accordance with the Protocol.
Safety Reports. The District shall make available, pursuant to the California Public Records Act, any annual report in compliance with applicable laws and District safety policies. A copy will be on file and available for inspection, as required by the California Public Records Act, in the office of the Vice Chancellor, Finance & Administration.
Safety Reports. Each year the District is required by OSHA to post a summary of work-related injuries/illnesses for the prior year using OSHA Form 300A. Copies are posted at all District sites and may be requested, as required by the California Public Records Act, from the office of the Vice Chancellor, Finance & Administration. The Clery Act requires that the District post an annual security report. This report is available on the homepage of the District and College websites.
Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in the Protocol(s). ICD must provide Collaborator with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human Subjects in research conducted under this CRADA.
Safety Reports. In accordance with FDA requirements, the Sponsor will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in the Protocol(s). The Sponsor must provide the other Party with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human Subjects in research conducted under this CRADA. DCTD shall report all serious and/or unexpected Adverse Events to FDA in accordance with the reporting obligations of 21 CFR 312.32 and will, within 24 to 48 hours of notification to FDA, forward all such reports to Collaborator. All other Adverse Event reports received by DCTD shall be reported to the FDA consistent with 21 CFR 312.32 and 312.33. In the event that Collaborator informs the FDA of any serious and/or unexpected Adverse Events, Collaborator must notify the NCI at the same time by sending the reports to XXXXXxxxxxxXX@xxxx-xxx.xxx. NCI will then notify the Clinical Investigator(s) conducting studies under DCTD-sponsored protocols, if appropriate.
Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in PHS ICT-CRADA Case Ref. No.02661 MODEL ADOPTED June 18, 2009 the Protocol(s). ICD must provide Collaborator with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human Subjects in research conducted under this CRADA.
Safety Reports. DCTD shall report all serious and unexpected possible, probable and definite Adverse Events to FDA in accordance with the reporting obligations of 21 CFR 312.32 and will, within 24 hours of notification to FDA, forward all such reports to Collaborator. All other Adverse Event reports received by DCTD shall be reported to the FDA consistent with 21 CFR 312.32 and 312.33. In the event that Collaborator informs the FDA of any serious and unexpected Adverse Events, Collaborator must notify the NCI at the same time. NCI will then notify the Clinical Investigator(s) conducting studies under DCTD-sponsored Protocols, if appropriate.
Safety Reports. During the performance of the Work, the Contractor will provide OPG’s Representative with:
(1) a verbal report immediately (and evidence of such verbal report by a senior executive of the Contractor) of all accidents, near misses or any incidents that result in, or could reasonably be expected to result in, death from either immediate or delayed effects or permanent total disability, that is, where an individual is disabled to the point where maintaining gainful employment is unlikely (a “High Maximum Reasonable Potential for Harm Incident”), which the Contractor is required to provide to OPG in accordance with OPG’s safety incident management standard, a copy of which has been made available to and reviewed by the Contractor, including any serious incident requiring off-site medical attention or near miss incidents, which in each case has or could have resulted in the death of, or serious injury to, a worker or other person on or off the Site;
(2) in addition to any immediate verbal report that is required under Section (i)(1) of this Schedule 2.8, as applicable, within 24 hours of an accident, construction occurrence or incident report, a copy of all accident, construction occurrence and incident reports which the Contractor, any Subcontractor, or OPG is required to submit in respect of the Work under the Occupational Health and Safety Act (Ontario) or the Workplace Safety and Insurance Act, 1997 (Ontario);
(3) within 24 hours, Notice of any visits by the Ministry of Labour and copies of any reports, orders to comply, charges, stop work orders, and notices of compliance under the Occupational Health and Safety Act (Ontario) or other Applicable Laws;
(4) a copy of the minutes of each meeting of the JHSC; and
(5) a monthly report within ten days of each month’s end with safety statistics for Contractor and all Subcontractors providing Work at the Site. The Contractor will include in this report, with a brief description of each incident and injury:
(A) the number of injuries resulting in a worker requiring medical aid;
(B) the number of near miss incidents which could have resulted in the death of, or serious injury to, a worker;
(C) the number of injuries resulting in a worker’s absence from one or more complete shifts;
(D) the time off each worker takes off from work for each injury;
(E) the number of Ontario Ministry of Labour orders to comply received by the Contractor or a Subcontractor; and
(F) the total number of person hours worked by the Contracto...
Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations. In the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs, as well as procedures specified in the Protocol(s). ICD must provide Collaborator with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human Subjects in research conducted under this CRADA. ICD shall report all Serious and/or Unexpected Adverse Events to FDA in accordance with the reporting obligations of 21 CFR 312.32. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
4.4.1 Within 24 to 48 hours of notification to FDA of any SAE related to Test Article affecting the safety of Human Subjects in clinical studies conducted under this CRADA that requires expedited reporting to the FDA (either a 7-day or 15-day report), ICD will notify Collaborator’s Chief Medical Officer or such other Collaborator designee and provide all related reports to Collaborator. All other Adverse Event reports received by ICD shall be reported to the FDA consistent with 21 CFR 312.32 and 312.33.
4.4.2 Within 24 to 48 hours of notification to FDA of any SAE affecting the safety of Human Subjects in clinical studies for Tarmogens within or outside the scope of this CRADA that requires expedited reporting to the FDA (either a 7-day or 15-day report), Collaborator or its designee will notify and provide all related reports to ICD.
4.4.3 When feasible, Parties will notify each other of any SAE covered by sections 4.4.1 or 4.4.2 in advance of notifying FDA. In the event that Collaborator informs the FDA of any Serious and/or Unexpected Adverse Events, Collaborator must notify ICD at the same time by sending the reports to XXXXXxxxxxxXX@xxxx-xxx.xxx. ICD will then notify the Clinical Investigator(s) conducting studies under ICD-sponsored protocols, if appropriate.
